In mid-November, 2011, FDA’s Center for Drug Evaluation and Research (CDER) presented a webinar, “Introduction to the Drug Master File (DMF).”
Presenting was Arthur Shaw, CDER’s DMF Expert, who is also a quality reviewer in the Office of New Drug Quality Assessment (ONDQA).  He has extensive experience in dealing with DMF filing and database issues, as well as reviewing many DMFs for technical content as part of his daily review work to support New Drug Applications (NDAs) and Investigational New Drug (IND) applications.
Shaw discussed all aspects of filing a DMF, including: â—Ź when and why to submit a DMF â—Ź requirements and recommendations for formatting and submitting original DMFs and subsequent submissions â—Ź how DMFs are reviewed, and â—Ź common problems (see link below).
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